Details for New Drug Application (NDA): 021528
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The generic ingredient in ACULAR LS is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 021528
Tradename: | ACULAR LS |
Applicant: | Abbvie |
Ingredient: | ketorolac tromethamine |
Patents: | 8 |
Pharmacology for NDA: 021528
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021528
Suppliers and Packaging for NDA: 021528
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528 | NDA | Allergan, Inc. | 0023-9277 | 0023-9277-05 | 1 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) / 5 mL in 1 BOTTLE, DROPPER |
ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-3550 | 50090-3550-0 | 1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.4% | ||||
Approval Date: | May 30, 2003 | TE: | AT | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 24, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 28, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 28, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 021528
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR LS | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 021528-001 | May 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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